Medical Director - Early Development - Digital Medicine

Thousand Oaks, CA, US
Aug 09, 2019
Required Education
Masters Degree/MBA
Position Type
Full time
The Amgen Transnational Medicine Group is recruiting for a Medical Director position to lead strategic early development programs incorporating the use of digital technologies into clinical trials, with the goal of understanding, developing, and validating novel digital biomarkers and endpoints. Responsibilities may include designing and executing clinical trials that involve remote sensors, software, hardware, networks, data analytics, and other emerging technologies.

Role Responsibilities Include:
  • Effectively networks with internal and external opinion leaders and collaborates with other digital health stakeholders within Amgen.
  • Designs and implements science-driven innovative early clinical development digital biomarker strategy; and contributes to the development and use of novel digital clinical biomarkers to facilitate drug development.
  • Leads the preparation of clinical development plans and clinical study protocols, and contributes digital medicine guidance to informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions.
  • Reviews and evaluates clinical study safety, efficacy, and pharmacokinetic data.
  • Actively collaborates with Amgen Digital Health, Patient Engagement, Global Development Operations, Data Science, Dev IS, and early-stage and late-stage clinical development, regulatory, and commercial colleagues.
  • Contributes to in-licensing evaluations and due-diligence activities.
  • Collaborates with external experts to provide biomedical expertise and strategic guidance to early development teams.
  • Participates in relevant external industry consortia to advance digital biomarker research, establish industry standards, and contribute to regulatory guidance development.

Basic Qualifications

MD/DO, PhD or PharmD with 2 years of clinical research and/or basic science research experience

Preferred Qualifications
  • Experience in designing, monitoring and implementing clinical trials and interpreting trial results.
  • 3 or more years of drug development experience obtained while working in the pharmaceutical industry and/or substantial clinical trial experience collaborating with pharmaceutical sponsors.
  • Familiarity with early phase development and regulatory filings
  • Strong passion and successful track record for leveraging digital technologies to improve quality, affordability, and access to health care.
  • Experience with the use of wearable sensors, digital health, mobile health, analytics, or other technology applications in a clinical setting.
  • Familiarity with evolving regulatory guidance around new healthcare technologies.
  • Business understanding of the digital health market and the broader technology industry, including wearable sensors, machine learning, blockchain, and other developments.
  • Familiarity with emerging healthcare trends, including value-based payment, real-world evidence, consumerization, and virtual care.
  • Experience functioning within a matrix environment.
  • Publication track record.
  • Experience with presenting and communicating to a broad array of audiences.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.



Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.